An open-label, non-randomised, uncontrolled, proof-of-concept study of eight patients with 'definite' HTLV-I-associated myelopathy/Tropical Spastic Paraparesis (HAM/TSP). Eligible patients will have either early disease (of less than 2 years duration) or progressive disease (with observed clinical deterioration during the preceding 3 months.

Following 2 baseline assessments including Magnetic Resonance Imaging (MRI) of the spinal cord and a lumbar puncture for examination of the fluid around the brain (CSF) participants will be treated with a total of 7 infusions of the anti-TNF-alpha antibody infliximab over a period of 48 weeks. After the last on therapy assessment at 48 weeks participants will be followed up for a further 24 weeks. Study assessments will be clinical, virological, immunological and radiological. MRIs of the spinal cord will be obtained at weeks 12 and 72. CSF will be examined, on therapy, at week 12.

Infliximab 3mg/kg infused intravenously at weeks 0, 2 and 8 and then every 8 weeks until and including week 40 of the study

Drug: Infliximab

Infliximab 3mg/kg infused intravenously at weeks 0, 2 and 8 and then every 8 weeks until and including week 40 of the study

Eligibility

Ages Eligible for Study:

16 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Are able to give informed consent

Are 16 years or older

Have 'definite' HAM/TSP according to the criteria of "Definite HAM/TSP" agreed in Belem 200361

Have early or progressing disease as defined here:

"Early HAM/TSP": Patients must have motor disability (minimum of stiffness or weakness) for less than 2 years. (Bladder symptoms if the original and only presenting symptoms as assessed by history are not included)

"Progressing HAM/TSP"

New or worsening motor symptoms in a patient with definite HAM of > 2 years duration within the last 3 months

Exclusion Criteria:

Hepatitis B or hepatitis C infection

HIV infection

Overt sepsis, abscesses or opportunistic infections

Active TB (untreated or on treatment)

Strongyloides stercoralis (untreated)

Known hypersensitivity to inflixmab, other murine proteins or to any of the excipients

Malignancy

Moderate or severe heart failure (NYHA class III/IV)

Pregnancy or breastfeeding

Unhealed surgical wounds

Planned impending surgery - treatment would be withheld for 2-4 weeks prior to major surgery and started/restarted post-operatively if no evidence of infection and wound healing is satisfactory

Current immunosuppressive or immunomodulatory therapy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823641

Locations

United Kingdom

Imperial College Healthcare NHS Trust

London, United Kingdom, W2 1PG

Sponsors and Collaborators

Imperial College London

Medical Research Council

Investigators

Principal Investigator:

Graham P Taylor, MD

Imperial College London

More Information

No publications provided

Responsible Party:

Graham Taylor, Reader in Communicable Diseases, Imperial College London